A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Tenuate Warnings, Precautions, Pregnancy, Nursing, Abuse - Diethylpropion
Tenuate Warnings, Precautions, Pregnancy, Nursing, Abuse - Diethylpropion
WARNINGS
If tolerance develops,
the recommended dose should
not be exceeded in an attempt to increase the effect; rather, the
drug should be discontinued.
TENUATE or TENUATE DOSPAN may impair the ability
of the patient to engage
in potentially hazardous activities such
as operating machinery or driving a motor
vehicle; the patient
should therefore be cautioned accordingly.
When central nervous
system active agents
are used, consideration must always be given to the possibility
of adverse interactions with alcohol.
PRECAUTIONS
General
Caution is to be exercised in prescribing TENUATE or TENUATE DOSPAN
for patients with hypertension
or with symptomatic
cardiovascular
disease, including arrhythmias. TENUATE or TENUATE DOSPAN should
not be administered to patients with severe hypertension.
Reports suggest that diethylpropion hydrochloride
may increase convulsions in some epileptics. Therefore, epileptics
receiving TENUATE or TENUATE DOSPAN should be carefully monitored.
Titration of dose or discontinuance
of TENUATE or TENUATE DOSPAN may be necessary.
The least amount feasible should be prescribed or dispensed at
one time in order to minimize
the possibility of overdosage.
Laboratory Test: None
Carcinogenesis, Mutagenesis, and Impairment of Fertility
No long-term animal
studies have been done to evaluate diethylpropion hydrochloride
for carcinogenicity. Mutagenicity studies have not been conducted.
Animal reproduction
studies have revealed no
evidence of impairment
of fertility (see Pregnancy, below).
Pregnancy
Teratogenic Effects: Pregnancy Category B. Reproduction
studies have been performed in rats at doses up to 9 times the human
dose and have revealed no
evidence of impaired
fertility or harm
to the fetus due to diethylpropion hydrochloride. There are, however,
no adequate and well-controlled
studies in pregnant
women. Because animal
reproduction studies are not always predictive of human
response, this drug should
be used during pregnancy
only if clearly needed.
Non-Teratogenic Effects: Abuse with diethylpropion hydrochloride
during pregnancy may
result in withdrawal
symptoms in the human
neonate.
Nursing Mothers
Since diethylpropion hydrochloride
and/or its metabolites have been shown to be excreted in human
milk, caution should be exercised when TENUATE or TENUATE DOSPAN
is administered to a nursing
woman.
Pediatric Use
Since safety and effectiveness
in children below the age
of 12 have not been established, TENUATE or TENUATE DOSPAN is not
recommended for use in children under 12 years of age.
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